Human Subjects Research

University of Vermont (UVM) and UVM Medical Center are involved in important behavioral and biomedical research and are committed to assuring that all research activities are conducted in a manner that promotes the rights and welfare of the participants. The two committees listed below are responsible for reviewing and overseeing all research activities, and are known as the Institutional Review Boards (IRBs).

CHRMS - Committee on Human Research in the Medical Sciences

CHRBSS - Committee on Human Research in the Behavioral and Social Sciences

UVMClick – IRB Implementation Plan

Go Live Clock:

InfoEd editing was turned off on Nov 2, at 4:30 pm. View access is still available. We encourage continued responses to pending items from Nov 3 to 14 outside of the InfoEd system by the following method:

Only responses to clarifications may be submitted during this time (new protocols, new amendments, etc., will not be considered),

You must email your response letter and any revised protocol materials directly to your Research Analyst,

Approvals of these responses will be managed through InfoEd (by IRB staff only) therefore, you will receive correspondence from that system until the submission is approved.

Note: No one, not even RPO staff, will have view/edit access on Nov 15 to 18

Required UNIVERSITY OF VERMONT - CITI PROGRAM Course(s)

IRB - HUMAN SUBJECTS

Biomedical Research (Refreshers are required every three years)

OR

Social Behavioral Education Sciences (Refreshers are required every three years)

All individuals involved in the conduct of research with human subjects, regardless of funding source, must complete either the “Biomedical Research” or “Social Behavioral Education Sciences” course option.

Principal Investigators on all protocols including exempt

Key Personnel listed on active nonexempt protocols*

Non-Faculty (Students)

Faculty Sponsors

Class Instructors

*While key personnel working on exempt projects are not required to complete the human subjects training, completion is strongly recommended. Not research and not human subjects projects do not require key personnel to complete training.

Other CITI course(s):

The "Research Involving Prisoners" (required if conducting research that studies a prisoner population) and "Additional Consent Training" (optional) do not meet all the requirements for human subjects research. You will still need to complete either the “Biomedical Research” or “Social Behavioral Education Sciences” course option to meet the requirements for human subjects research.

*All UVM employees are issued a UVM NetID upon hire, but there are many UVMMC (non-UVM) research key personnel who do not have a UVM NetID. A UVM NetID can be issued to UVMMC personnel to access the InfoEd system. If you do not have a UVM NetID, complete and submit the Request for UVM Net ID form (DOC) to RPO in order to gain access.

Step 4: Using InfoEd

The best practice is to have all uploads ready before creating a new submission/protocol. Then create the submission/protocol, upload the required documents and submit the request on the same day. That way we know nothing is extraneous and it can be processed most efficiently.

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Cooperative Research (Single IRB)

The definition of cooperative research is any research project that involves more than one institution. At this time, UVM IRB will not act as a lead single IRB nor will it rely on external IRBs for any non-NIH funded projects as there are insufficient resources.

IRB Policies and Procedures Manual

Federalwide Assurance (FWA) and IRB Registration

An Assurance is the documentation of institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human participants. This is the principal mechanism for compliance oversight by the Office for Human Research Protections. The University of Vermont Institutional Review Boards (IRBs) which serve the University of Vermont and UVM Medical Center are organized and operate in compliance with the US Department of Health and Human Services and the Food and Drug Administration regulations.

The IRBs that serve the two institutions are registered to the University of Vermont and State Agricultural College (IORG 0000289) with the Department of Health & Human Services. Registration numbers for the IRBs are:

IRB Newsletters and Special Notices

A program of continuing education and training in the protection of human subjects is a federal requirement. We use our IRB listserve and specifically the Newsletters to partially fulfill this mandate. Key personnel listed on each protocol are required to receive and review information provided in this listserve. If at any time key personnel lose their ability to receive these notices (based upon return email notice), the principal investigator will be notified of the problem. Those key personnel will be inactivated in our system until the problem has been resolved. Of note, key personnel who have been inactivated in the IRB system should not be participating in any research until they have been reactivated.

Special Notice – Common Rule Delay

Common Rule Delay

As the January 19 Common Rule effective date was closing in on us, last evening at 4:52 pm, we receive notice from our regulators that an Interim Final Rule (IFR) was approved to delay both the effective date and general compliance date until July 19, 2018. The IFR has not been published, but may be found on the Federal Register (opens in a new window) as unpublished until the scheduled publication date of January 22, 2018.

The Council on Governmental Relations (COGR) released their initial thoughts on the delay.

“An eleventh hour delay of both the effective and compliance dates, however well-intentioned, presents a challenge to institutions which have strived to comply with the revised final rule on January 19, 2018 as required by regulation prior to yesterday’s notice of a pending IFR. Continued uncertainty about the final effective and compliance date with the proposal of additional rulemaking will add to that challenge.”

We concur with COGR’s assessment on this last minute delay. Yesterday, RPO staff were running to the finish line to meet the compliance date, now we are working diligently to “reverse” steps that we had already put into place to address, in particular, the change to the continuing review of non-exempt research. Researchers conducting expedited-level protocols now must continue to submit continuing reviews to comply with the pre-2018 rule. Researchers will continue to receive the standard continuing review notices. However, if you are unclear as to whether you need to submit a continuing review or not, please contact our office at 656-5040. The delay does provide us additional time to refine changes to exemption processes as well as develop additional educational materials about the changes.

What this Means for Researchers

This delay means that we are unable to roll out changes that conflict with the pre-2018 Common Rule. The following changes do conflict with the pre-2018 rule and therefore, will not be implemented at this time:

Continuing Review Changes

Exemption Category

Changes Changes that do not conflict with the pre-2018 Common Rule and will be implemented:

Informed Consent Changes

Single IRB for NIH funded projects (compliance date January 25, 2018)

Single IRB for all other cooperative research (2020)

Please see the Regulatory Changes (opens in a new window) web page for information specific to the Informed Consent changes. If you have questions, please do not hesitate to contact your IRB Research Analyst for assistance. Within the week, we will release a new and improved research manual and two new dictionaries, one specific to regulatory definitions and one specific to consent language. We hope you find these new resources helpful.

Special Notice – Instructor Assurance

Changes to Instructor Assurances as a Result of the New Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

The rule adds to and modifies existing Exemptions. This includes modifying previous Exemptions to allow use of identifiable information with limited IRB review (which is a new category of review that requires an IRB member); inclusion of benign behavioral interventions; and storage, maintenance and secondary use of identifiable private information and identifiable biospecimens where broad consent is obtained.

The changes to the Exemption categories, while trying to reduce overall burden, are significantly more complicated requiring related experience and training in making appropriate Exemption determinations. Therefore, we will be retiring the Instructor Assurance process.

Locally and nationally, the majority of classroom projects are not considered research by Federal definition and do not require IRB review. If the intention of the class project meets the following criteria, then the project would not meet the definition of research and would not require IRB submission.

It is an activity designed as part of a course requirement for purposes of learning research methods and;

The results and data will not be used for any presentation, conference, publication, thesis, dissertation, or report outside of the course for which it is assigned.

If the student’s required classroom project does not meet the criteria above, an IRB submission is necessary. There will no longer be an option for the Instructor to make Exemption determinations for their student’s class project. A student project felt to be research defined by Federal regulations will need to submitted to the IRB for review. See attached Student Class Guidance for your responsibilities as the Class Instructor in these instances.

This new requirement does not apply to the Spring 2018 semester classes currently in progress. However, Investigators will need to look ahead at any Summer and Fall classes to ensure student class projects that are research are submitted to the RPO Office.

Special Notice – Consent Form Changes

Common Rule Changes to the Consent Templates

Changes to the Common Rule, the primary rule regulating human subjects research, go into effect on January 19, 2018. A number of UVM IRB policies, procedures, and systems have been updated as a result of the changes to the rule.

Investigators will see a number of changes required under the new rule specific to the Consent Form:

“The informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”

All medical and behavioral consent forms will now be required to include a concise summary of study activities, risks, and benefits presented to research participants, on page one of the consent document. The IRB will not require re-consent for previously enrolled subjects.

Please note that only studies approved or altered after January 19, 2018 will be governed by the new rule; the IRB will grandfather all existing approved consent forms under the pre-2018 rule.

IRB applications submitted shortly before January 19, 2018 may not be reviewed in time to qualify under the current human subjects protection regulations. Applications undergoing the review process at the time of transition may be returned to the study team to update the informed consent elements.

Additional Education Materials

Human Gene Transfer

“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”

Effective April 27, 2016, UVM Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. If the project is sponsored, the sponsor is responsible for determining if RAC review is required.

Review and approval of a gene transfer protocol can be complex, therefore we have developed a step-by-step guide for submission of a human gene transfer protocol at UVM/UVMMC.

UVM Medical Center Information

UVM Medical Center Research Subject Registrations

As of January 1, 2014 researchers and research staff will need to complete a registration form for any UVM Medical Center patients executing a new consent form to participate in a research study. For more information please see annoucement from UVM Medical Center (PDF).

Completed forms must be submitted to “Registration – Research Studies” Outlook Mailbox (registrationresearchstudies@uvmhealth.org) or FAX to 847-4179.